The Engineer, Software Quality - Senior or Lead will be responsible for ensuring all validation projects comply with 21 CFR Part 11 requirements. This compliance-focused role includes managing validation, data integrity, cybersecurity, periodic reviews, change management, CAPAs, and audit support. Acting as the division's subject matter expert for non-product software lifecycle policy and procedures, the individual will ensure adherence to regulatory and internal standards while supporting quality system objectives. The role demands strong collaboration with senior management and requires technical expertise, high confidence, and leadership.

Key Responsibilities :

Compliance and Validation :

• Ensure validation activities align with 21 CFR Part 11 , 820 , Annex 11 , GAMP5 , ISO 13485 , and ISO 27001 standards.
• Review and assess software lifecycle deliverables, including supplier evaluations and documentation, for compliance.
• Provide oversight and ensure periodic reviews, change management processes, and CAPAs meet compliance requirements.

Quality System Oversight :

• Act as a compliance expert for non-product software across multi-site and division-wide activities.
• Collaborate with various stakeholders to manage software lifecycle deliverables.

Audit and Data Integrity :

• Support internal and external audits, addressing any software lifecycle issues.
• Drive adherence to data integrity standards and cybersecurity requirements.

Project Management :

• Lead large-scale projects, ensuring they are completed on schedule, within scope, and budget constraints.
• Interface with senior management to provide updates, insights, and recommendations.

System and Tool Expertise :

• Utilize Quality Management and Test Management tools such as TrackWise , ComplianceWire , Veeva , ALM , and JIRA to oversee quality processes.
• Manage activities related to SaaS, IaaS, PaaS, COTS, and custom applications.

Required Qualifications :

• Education :
• Bachelor's degree with 8+ years of experience , or Master’s degree with 5+ years of experience .
• (Graduation year must be included in resumes.)
• Industry Experience :
• Prior experience in the healthcare industry (Pharma/Biotech) is mandatory.
• Proven experience with GxP systems in a regulated environment.

Top Skills & Requirements :

Regulatory Expertise :

• In-depth knowledge of FDA regulations , including 21 CFR Part 11 , 820 , and Annex 11 .
• Familiarity with GAMP5 , ISO 13485 , and ISO 27001 standards.

Tools and Systems Knowledge :

• Proficiency with TrackWise , ComplianceWire , Veeva , ALM , and JIRA .

Data Integrity and Audits :

• Strong understanding of Data Integrity principles and audit support (internal/external).

Software Lifecycle Expertise :

• Experience with SaaS, IaaS, PaaS, COTS, and custom software applications.

Leadership and Communication :

• Ability to confidently interface with senior management and lead cross-functional teams.

Preferred Skills :

• Demonstrated experience managing compliance-focused software validation projects.
• Prior success in multi-site or division-wide initiatives.